MITRAClip GENeration 5 Mitral Valve Transcatheter Edge-to-Edge Repair Registry

The MITRAGEN5 Registry is an international, multicenter, observational registry that collects data on patients with mitral regurgitation who are treated with the fifth-generation MitraClip (G5) device. The MitraClip is a small device used to repair the mitral valve of the heart without open-heart surgery, a procedure called mitral valve transcatheter edge-to-edge repair (M-TEER). This registry aims to evaluate how safe and effective the MitraClip G5 is in everyday clinical practice across multiple hospitals worldwide. All procedures, tests, and follow-up visits are part of routine clinical care. No additional study-specific procedures are performed. Data are collected in anonymized form from participating centers.

The MitraClip system is the most widely used device for mitral valve transcatheter edge-to-edge repair of mitral regurgitation. The fifth generation (G5) introduces iterative enhancements to the delivery platform, including a redesigned steerable guide catheter, updated stabilizer with a new guide attach feature, and refined attachment and securement mechanisms - aimed at facilitating device handling, positioning, and procedural efficiency. The clip sizes and their fundamental design remain unchanged from the fourth generation. This investigator-initiated registry aims to collect comprehensive real-world data from international high-volume centers to characterize the safety and effectiveness of the MitraClip G5 in a broad patient population treated according to local clinical practice. Enrollment includes both retrospective data from patients treated since the introduction of the MitraClip G5 at each center and prospective data from ongoing clinical use. Data collection includes baseline clinical and echocardiographic characteristics, procedural details, in-hospital outcomes, and follow-up information available from routine clinical care. Each participating site is responsible for data anonymization prior to transfer to the coordinating center (University Hospital Cologne, Germany). No patient-identifiable information is shared.

Inclusion Criteria: * Age 18 years or older at the time of M-TEER * Treatment using the MitraClip G5 system Exclusion Criteria: \- None